Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).

This device is not intended for mammography and pediatric patients.

Device Description

This Digital Radiography System (ManntiX K) is a portable digital device developed, designed and manufactured by Shenzhen Browiner Tech Co., Ltd. A detailed comparison table with an equivalent device are in 510(k) summary. The device consists of the following major components: portable X-ray Assembly, X-ray Protective Device, Mobile Stand, Digital Detector, image processing system. The difference between ManntiX B and ManntiX K are as below.

Model	ManntiX B	ManntiX K
Portable X-ray Assembly (including collimator and tube)	PX10	PX10 Pro
X-ray Protective Device (optional)	BA-01
Mobile Stand	MS-05P	MS-10P
Digital Detector (optional)	CareView 1500Cwe
	Mars1717X
	Luna 1012X
Image Processing System (optional)	MOC (V03)
Image Acquisition Workstation (optional)	BWS-10

Note:

1. ManntiX B and ManntiX K are delivered with one of CareView1500Cwe, Mars1717X and Luna 1012X, or two of them, or three of them.
1. A computer system, necessary for image viewing and manipulation, is not part of the device.

The major components of Digital Radiography System include: portable x-ray assembly, x-ray protective device, mobile stand, digital detector, image processing system, image acquisition workstation.

Portable X-ray assembly including collimator and tube, produces X-rays at the clinically required dose; X-ray protective device is used to protect the human body during diagnostic radiography; mobile stand is used to support or hang X-ray source components; digital detector receives X-ray signals and converts them into visible light, which is converted into electrical signals by photoelectric elements and then converted into digital signals by analog-to-digital conversion before being transmitted to the computer; image processing system has multiple functions. including new patient registration, image acquisition and processing, data transmitting, etc; image acquisition workstation is used in addition to the image processing system to adjust exposure parameters, check the status of the entire machine, and view logs.

AI/ML Overview

The provided document is a 510(k) summary for a Digital Radiography System (ManntiX B, ManntiX K). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving that the device meets those criteria, especially in the context of an AI/ML-driven device's performance.

The document primarily focuses on:

Regulatory information: FDA review, regulations, and contact details.
Device description: Components, technical specifications (generator, detector, image processing), and intended use.
Comparison to a predicate device: Highlighting similarities in intended use, technology, and functionality to establish substantial equivalence.
Non-clinical performance tests: Listing compliance with various IEC and ISO standards related to electrical safety, electromagnetic compatibility, radiation protection, software lifecycle, and usability.
Biocompatibility: Statement of evaluation according to ISO 10993-1.

There is no mention of:

Specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) beyond general safety and electrical performance standards.
A study proving the device meets such acceptance criteria.
Sample sizes for test sets, data provenance, expert ground truth adjudication (for AI/ML performance evaluation), MRMC studies, standalone performance, type of ground truth used (pathology, outcomes), or training set details.

This type of 510(k) submission primarily demonstrates that the proposed device is as safe and effective as a legally marketed predicate device, often through a comparison of technical specifications and adherence to recognized standards. It does not typically involve the detailed clinical or AI/ML performance evaluation aspects you've asked about unless the device incorporates novel AI/ML components that significantly alter its diagnostic output or workflow. In this case, the device is a Digital Radiography System, which is an imaging modality, and the details provided relate to the hardware and image acquisition/processing capabilities rather than an AI/ML diagnostic aid.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

December 9, 2024

Shenzhen Browiner Tech Co., Ltd % Long Yang COO Shenzhen Hlongmed Biotech Company 16th floor, Tianming Technology Building, No.8 Wushitou Road Songpingshan Community, Xili Street, Nanshan District Shenzhen, GD 518052 CHINA

Re: K240841

Trade/Device Name: Digital Radiography System (ManntiX B, ManntiX K) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL, MOB, LLZ Dated: November 5, 2024 Received: November 5, 2024

Dear Long Yang:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240841

Device Name

Digital Radiography System (ManntiX B, ManntiX K)

Indications for Use (Describe)

This device is not intended for mammography.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(K) number is: K240841

1. Submitter

Shenzhen Browiner Tech Co., Ltd

Room 501, Building C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, PEOPLE'S REPUBLIC OF CHINA

2. Contact Person

2.1 Primarv Contact Person

Long Yang (COO)

Shenzhen Hlongmed Biotech Company

16th floor, Tianming Technology Building, No.8 Wushitou Road, Songpingshan Community, Xili Street, Nanshan District, Shenzhen, P.R.C

Tel: 0086-755-86664986

Fax: 0086-755-86664933

E-mail: yanglong@hlongmed.com

2.2 Secondary Contact Person

Li Chen(RA engineer)

Shenzhen Browiner Tech Co., Ltd

Room 501, Building C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, PEOPLE'S

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REPUBLIC OF CHINA

Tel: 0086-15752770581 Fax: 0086-755-22674695 E-mail: lichen@browiner.com

Date Prepared: December 5, 2024

4. Proposed Device Information

Trade name: Digital Radiography System (ManntiX B, ManntiX K) Regulation Name: Mobile X-Ray System Classification name: System, X-Ray, Mobile Review Panel: Radiology Product Code:Primary Product Code: IZL; Secondary Product Code: MQB, LLZ Regulation Class: II Regulation Number: 21 CFR 892.1720

5. Predicate Device Information

Manufacturer	Proprietary /Trade Name	510(K) Number
Shantou Institute ofUltrasonic InstrumentsCo., Ltd. (SIUI)	SR-2300 Portable DR Imaging SystemSR-2300S Portable DR Imaging System	K202353

Device Name: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

Regulation Name: Mobile X-Ray System

Classification name: System, X-Ray, Mobile

Review Panel: Radiology

Product Code:Primary Product Code: IZL; Secondary Product Code: MQB, LLZ

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Regulation Class: II Regulation Number: 21 CFR 892.1720

6. Device Description

Model	ManntiX B	ManntiX K
Portable X-ray Assembly (including collimator and tube)	PX10	PX10 Pro
X-ray Protective Device (optional)	BA-01
Mobile Stand	MS-05P	MS-10P
Digital Detector (optional)	CareView 1500Cwe
	Mars1717X
	Luna 1012X
Image Processing System (optional)	MOC (V03)
Image Acquisition Workstation (optional)	BWS-10

Note:

1. ManntiX B and ManntiX K are delivered with one of CareView1500Cwe, Mars1717X and Luna 1012X, or two of them, or three of them.
1. A computer system, necessary for image viewing and manipulation, is not part of the device.

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The major components of Digital Radiography System include: portable x-ray assembly, x-ray protective device, mobile stand, digital detector, image processing system, image acquisition workstation.

7. Intended use

Intended for use by a qualified/trained physician or technician for the purpose of acquiring Xray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).

This device is not intended for mammography and pediatric patients.

8. Comparison to Predicate Device

Radiography System have the similar intended use, use, similar The Digital technological characteristics as the following predicate device. Subject Device is substantially equivalent in its technologies and functionality to the SR-2300 Portable DR Imaging System/SR-2300S Portable DR Imaging System manufactured by Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) that is already cleared under premarketed notification number K202353.

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The details of the technological characteristics of the subject device ManntiX versus the predicate SR-2300 are as stated below:

Item	Proposed Device	Predicate Device
Device Name	Digital Radiography System	SR-2300 Portable DR Imaging SystemSR-2300S Portable DR Imaging System
Model	ManntiX BManntiX K	SR-2300SR-2300S
510(k) number	K240841	K202353
Submitter	Shenzhen Browiner Tech Co., Ltd	Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
Intended use	Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography and pediatric patients.	Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography.
Indications for use	Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography and pediatric patients.	Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography.
BasicGeneratorCharacteristics	Peak generator	5W
	Maximum Power kW: 10 kW (100 mA, 100 kV)Nominal Power kW: 8 kW (80 mA , 100 kV, 100 ms)
	Tube current	5-160 mA, ±20%.Contain the following mA slot:
		10-100mA
Item	Proposed Device	Predicate Device
	22, 25, 28, 32, 36, 40, 45, 50, 56, 63,71, 80, 90, 100, 110, 125, 140, 160
Tube voltage adjustable range	40-125kV, step value 1kV	40-125kV, step value 1kV
mAs range	AC: from 0.1 mAs to 360 mAs, $\pm$ (10 % + 0.2 mAs).Contain the following mAs slot:0.1, 0.11, 0.125, 0.14, 0.16, 0.18, 0.2,0.22, 0.25, 0.28, 0.32, 0.36, 0.4, 0.45,0.5, 0.56, 0.63, 0.71, 0.8, 0.9, 1.0, 1.1,1.25, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8,3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1,8.0, 9.0, 10, 11, 12.5, 14, 16, 18, 20,22, 25, 28, 32, 36, 40, 45, 50, 56, 63,71, 80, 90, 100, 110, 125, 140, 160,180, 200, 220, 250, 280, 320, 360DC: from 0.1 mAs to 80 mAs, $\pm$ (10 % + 0.2 mAs).Contain the following mAs slot:0.1, 0.11, 0.125, 0.14, 0.16, 0.18, 0.2,0.22, 0.25, 0.28, 0.32, 0.36, 0.4, 0.45,0.5, 0.56, 0.63, 0.71, 0.8, 0.9, 1.0, 1.1,1.25, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8,3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1,8.0, 9.0, 10, 11, 12.5, 14, 16, 18, 20,22, 25, 28, 32, 36, 40, 45, 50, 56, 63,71, 80	0.4mAs-200mAs, with the range of:0.40, 0.50, 0.63, 0.80, 1.00, 1.25,1.6, ,2.0 ,2.5 ,3.2, 4.0, 5.0, 6.3, 8, 10,12.5 ,16, 20, 25, 32, 40, 50, 63, 80,100, 125, 160, 200
Collimator	Built in	Built in
X-ray Generator	One model, up to 125kVp	One model, up to 125kV
Operator console	Button Control or Touch Screen	Button Control or Touch Screen
Digital X-Ray	Mars1717X (K210314)	SFD-1X
Detectors	CareView 1500Cwe (K201932)
Item	Proposed Device	Predicate Device
Panel Shape	Mars1717X: Rectangular PanelCareView 1500Cwe: Rectangular PanelLuna 1012X: Rectangular Panel	Rectangular Panel


Detector Size	Mars1717X: 17"X17"CareView 1500Cwe: 14"X17"Luna 1012X: 10"X12"	14"X17"


Pixel Pitch	Mars1717X: 100 μmCareView 1500Cwe: 140 μmLuna 1012X: 100 μm	150 μm


Materials Scintillator	TFT -- amorphous Silicon	TFT -- amorphous Silicon
DQE	Mars1717X:51% at 1.0 lp/mm36% at 2.0 lp/mm25% at 3.0 lp/mm	36% at 1.0 lp/mm13% at 3.0 lp/mm



	CareView 1500Cwe:43% at 1.0 lp/mm30% at 2.0 lp/mm15% at 3.0 lp/mm



	Luna 1012X:51% at 1.0 lp/mm36% at 2.0 lp/mm25% at 3.0 lp/mm
MTF	Mars1717X:68% at 1.0 lp/mm38% at 2.0 lp/mm21% at 3.0 lp/mm	38% at 2.0 lp/mm



	CareView 1500Cwe:60% at 1.0 lp/mm32% at 2.0 lp/mm



Item	Proposed Device	Predicate Device
	17% at 3.0 lp/mm
	Luna 1012X:68% at 1.0 lp/mm38% at 2.0 lp/mm21% at 3.0 lp/mm
Communication	Wire	Wire
Method	Wireless	Wireless
	IEEE 802.11a/b/g/n/ac(2.4GHz/5GHz)	IEEE 802.11a/b/g/n (2.4GHz/ 5GHz)
	Security: WEP/WPA/WPA2	Security: WEP/WPA/WPA2
Components that cancommunicate wirelessly	Digital Detectors	Digital X-Ray Detectors
Type of scintillator	Amorphous silicon	Amorphous silicon
Type of use	Removable detector	Removable detector
Effective imaging area	Mars1717X: 430 mm × 430 mm;CareView 1500Cwe: 430 mm × 358 mm;Luna 1012X: 315 mm × 250 mm.Not less than 95% of the nominaleffective field of view	Not less than 95% of the nominaleffective field of view(430mm × 350mm).
Spatial resolution	Mars1717X: ≥5.0 lp/mmCareView 1500Cwe: ≥3.6 lp/mmLuna 1012X: ≥5.0 lp/mm	Not less than 3.6 lp/mm, without theattenuator module.
Grayscale	16 bit	Up to 16 bit.
Acquisition pixel	Mars1717X: 4267 × 4267CareView 1500Cwe: 3072 × 2560Luna 1012X: 3152 × 2502	Not less than 2500 × 3052.
Imaging time	Mars1717X: No more than 12s.CareView 1500Cwe: No more than10s.Luna 1012X: No more than 8s.	The fastest system imaging time is 8s.
Acquisition Software	MOC (V03)	PIE-5
Software function	Image viewingImage searchImage storage	Image viewingImage searchImage storage
Item	Proposed Device	Predicate Device
	Image annotation	Image annotation
	Image measurement	Image measurement
	Image processing	Image processing
	Image stitch	Image stitch
DICOM 3.0Compatibility	Yes	Yes
Photos	Image: Proposed Device Photo	Image: Predicate Device PhotoNote: The portable stand is an optional component.
Power Source	AC Line or rechargeable batteries	AC Line or rechargeable batteries
Standard	IEC 60601-1	IEC 60601-1
	IEC60601-1-2	IEC60601-1-2
	IEC60601-2-54	IEC60601-2-54
	IEC60601-1-3	IEC60601-1-3
	ISO 10993-1	ISO 10993-1
	IEC 62304	IEC 62304
	IEC 62366-1

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9. Biocompatibility

The Digital Radiography System have been evaluated in accordance with Part 10993 of the International Standard Organization (ISO). Standard tests administered include:

• ISO 10993-1 Fifth edition 2018-08

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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10. Summary of non-clinical performance Tests • IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

· IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

· IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

• IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

· IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software -

Software life cycle processes

• IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION

Medical devices - Part 1: Application of usability engineering to medical devices

11. Substantial Equivalent Conclusions

Digital Radiography System has the similar intended use, similar technological characteristics as the predicate device. Moreover, non-clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness.

In conclusion, Digital Radiography System is substantial equivalent to the predicate device.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.